Cleared Traditional

IL TEST(TM) UREA NITROGEN (K914877) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914877 · Instrumentation Laboratory CO · Chemistry device
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Mar 1992
Decision
134d
Days
Class 2
Risk

K914877 is an FDA 510(k) clearance for the IL TEST(TM) UREA NITROGEN. Classified as Urease And Glutamic Dehydrogenase, Urea Nitrogen (product code CDQ), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 11, 1992 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K914877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date March 11, 1992
Days to Decision 134 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDQ Urease And Glutamic Dehydrogenase, Urea Nitrogen

All 116
Devices cleared under the same product code (CDQ) and FDA review panel - the closest regulatory comparables to K914877.
Urea Nitrogen2
K203771 · Abbott Ireland Diagnostics Division · May 2022
UREA
K981918 · Abbott Laboratories · Jul 1998
TDX REA BUN
K853677 · Abbott Laboratories · Sep 1985
FOCUS UREA NITROGEN
K844755 · Abbott Laboratories · Jan 1985
A-GENT UREA NITROGEN
K810794 · Abbott Laboratories · Apr 1981
UN, UV DELTA TEST ASSAY
K770654 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1977